QFR — Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties Class II
FDA product code QFR covers "Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties", a Class II medical device regulated under 21 CFR 864.5430. Submissions are reviewed by the Hematology panel. At least 8 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QFR
- Device Class
- Class II
- Regulation Number
- 864.5430
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Definition
A coagulation system for the measurement of whole blood viscoelastic properties is an in vitro diagnostic device used to evaluate blood coagulation, fibrinolysis, or both, in patients.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251404 | Hemosonics | Quantra QStat Cartridge | Aug 25, 2025 |
| K240045 | Hemosonics | QStat Cartridge | Mar 27, 2024 |
| K232215 | Hemosonics | Quantra Hemostasis Analyzer | Aug 24, 2023 |
| K230461 | Hemosonics | Quantra Hemostasis Analyzer | Mar 24, 2023 |
| K223433 | Hemosonics | Quantra QPlus System | Dec 13, 2022 |
| K213917 | Hemosonics | QStat Cartridge | Nov 29, 2022 |
| K201513 | Hemosonics | Quantra QPlus System | Aug 21, 2020 |
| DEN180017 | Hemosonics | Quantra Hemostasis Analyzer, QPlus Cartridge | Mar 12, 2019 |